Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s plant in Beijing.
The Chinese firm had not established a link to an electronic portal for submitting electronic medical device reports, and the firm’s procedures didn’t define timelines for submitting MDRs.
Procedures for receiving, reviewing and evaluating complaints by a designated unit had not been established, the FDA investigators found, and there were no procedures for processing complaints outside of China.
Investigators noted that none of the complaints reviewed that occurred outside of the U.S. — for devices similar to those marketed in the U.S. — included documentation of the MDR evaluation, and when investigations were conducted, critical data were missing.
Design review procedures were also missing critical information such as when formal design reviews were held and who attended them. Results of design reviews were also not documented and retained in the design history file.
Design validation activities and design verification results also fell short, according to the Form 483. For example, design validation procedures didn’t ensure that validation was performed under defined operating conditions such as simulated-use conditions. Inspectors also noted that validation tests didn’t identify the unit under testing, the acceptance criteria, the dates of the testing or the test results.
“It was noted the testing was conducted prior to the start of the design project and no raw data was available for review,” the agency said.
During a review of CAPA activities, inspectors noted that not all sources of potential nonconformities were identified to detect recurring quality problems.
In addition, design verification results, including the identification of the design, were not properly documented in the design history file. Procedures for design change were not approved before changes were made to device designs, and document control procedures were not established to ensure that when changes were made, the revision numbers were updated, the agency said.
Read the Beijing Polycon Form 483 here: www.fdanews.com/10-30-18-beijingpolyconmedicalengineeringltd483.pdf.
Installation: Phase 1 of QSR-Compliant Equipment Control
The FDA expects devicemakers to follow Quality Systems Regulation-compliant procedures for installing equipment used in the course of device manufacture, including any ancillary equipment that affects production, such as environmental systems and contamination controls.
Installation could be as simple as plugging in a piece of equipment. On the other hand, it could be a complicated endeavor. Regardless of the complexity of the exercise, the FDA expects to see evidence that a devicemaker performed installation qualification, defined in Global Harmonization Taskforce (GHTF) guidance on the topic as establishing via objective evidence that all key aspects of the installation — including installation of ancillary equipment — meet approved specifications and that recommendations from the equipment supplier are suitably considered.
However, following the GHTF guidance will not ensure QSR compliance, says Dan O’Leary, president of Ombu Enterprises, noting that “QSR has got a lot more issues involved in it.”
Installation qualification is considered part of process validation, but it’s important to remember that it also stands alone for production equipment. Many qualification issues are going to be critical to the basic installation of equipment, O’Leary says.
Devicemakers must establish what characteristics are necessary for a piece of equipment to perform its intended task; these characteristics comprise the requirements, or specifications. For equipment purchased from an outside vendor, this information is included in the purchasing data. For equipment made in-house, the requirements are addressed in the design and construction parameters. O’Leary points out that this applies to test equipment as well as production equipment.
Ancillary systems that must be considered could include, depending on the specific production equipment, electric power or air systems, along with systems to manage discharges from the equipment in question. Installation covers physically placing the manufacturing equipment in a manufacturing environment and connecting to any ancillary equipment.
So devicemakers need to have clear procedures for how to hook up equipment to power, for instance. Other questions to answer regarding installation include whether the equipment will require air cooling or hook-up to water and whether it discharges a material or substance that will have to be routed somewhere and handled appropriately.
Excerpted from the FDAnews management report: Three Phases of QSR-Compliant Equipment Control.